Frequently fluids are provided to a patient by establishing a connection between the patient and a container housing the fluids. For example, medication may be provided by establishing a connection between the venous system of the patient and a container housing the medication. The medication may be supplied singularly or in solution with another fluid such as a saline or dextrose solution. The connection between the container and patient is typically established with an intravenous ("I.V.") administration "set." One method of providing the needed medication is to place the medication in an I.V. solution container before the container is supplied to a health care provider. Additional methods may include providing a portion of the solution to the provider, and injecting a supplemental medication into the container just before or during administration of the container contents to the patient.
Nutrition may also be provided to a patient by establishing a connection between a container containing nutritional fluid and a patient. The connection may be to a patient's venous or digestive system. During the "feeding" of a patient, supplemental fluids may need to be added to the container.
The medical solution or nutritional containers are typically formed with at least one port which provides or defines a passageway to the fluid contained within the container. To prevent leakage of fluid through the port, the container must include some manner or means for sealing the port. Should the function of the port be such that it is intended for a single insertion of a piercing member, forming a part of the administration set, to establish a fluid connection between the container and the set, the sealing member may take the form of a membrane stretched across the passageway. The piercing member may be referred to as a "spike". These types of ports are typically referred to as administration or "admin" ports.
It is also frequently necessary to establish intermittent access to the container fluid for the removal or addition of fluids such as medication or nutritional supplements to the container contents. The intermittent addition/removal port is sometimes referred to as the "med" port or site. In this instance, the site typically has a resealable access assembly which may be pierced by an access device, and then upon removal of the access device, the assembly reseals to prevent leakage from the container. This assembly includes a resealable member which may take the form of a solid rubber body, which must be pierced by a sharp cannula, such as a needle. The needle typically forms part of a syringe. However, use of a needle poses a danger of accidental "needle stick".
The resealable member may also take the form of a pre-slit septum which is adapted to be penetrated by a blunt cannula although use of the sharpened cannula is also acceptable. The blunt cannula is particularly adapted to overcome the potential danger of needle stick. Such septums and blunt cannulas are described in U.S. Pat. No. 5,135,489 is incorporated by reference herein.
These fluid filled containers may take many forms. One of the more prevalent forms is where the container is constructed as a flexible bag, which is suspended generally above the point of entry or access site into the patient. The bag container may be supplied with a single port or with a plurality of ports with one of the plurality being the administration port and another of the ports being the med port.
One method of fabricating the container is to place the fluid in the container during fabrication and then the assembled, fluid-filled container is subjected to a sterilization process. The preferred method of sterilization typically involves autoclaving or exposing the container to steam so that the container and its contents are subjected to a high temperature for an extended period of time. It has been found that this high temperature exposure may negatively impact on the performance characteristics of the components of known resealable access sites.
Also, generally the resealable septum is disposed within a housing particularly configured to position and compress the septum to maintain the resealable properties. It has also been found that these housings add an appreciable cost to a resealable access site and thus the cost of the container. As a large number of these containers are used by health care providers, any incremental cost has a large negative impact on the cost incurred in providing health care to a patient.
In addition to being employed on ports for fluid filled containers resealable septums are also employed in other devices such as injection sites, connector devices and blood sampling devices or the like. Providing particularly configured housings and resealable septums may add an appreciable cost to the manufacturing of these devices.
Therefore, it is an object of the present invention to provide a resealable access site for a fluid conveying conduit.
It is another object of the present invention to provide an improved resealable access site for a fluid-filled container, and more particularly, to provide an improved fluid access site for a container containing fluid which is to be administered to a patient.
It is a further object of the present invention to provide an improved resealable access site which may be pierced by an access device adapted to reduce the danger of accidental needle stick.
It is yet another object of the present invention to provide an improved access site for a fluid filled container in which the container and site may be exposed to high temperatures such as the temperatures present in a steam sterilization process.
It is yet another object of the present invention to provide an improved access site which may be economically fabricated. A related object is to provide such an access site which may be combined with a container containing fluid which is to be administered internally to a patient such as intravenously or parenterally.